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MAH(s): Pfizer Limited<br />
16.4.4. Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) –<br />
PANDEMRIX (CAP)<br />
<br />
Evaluation of PASS results<br />
Regulatory details:<br />
PRAC Rapporteur: Rafe Suvarna (UK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000832/II/0068 (without RMP)<br />
Procedure scope: Review of the data from the test-negative case-control analysis of a retrospective<br />
epidemiological study conducted in Quebec, Canada to evaluate the risk of narcolepsy associated with<br />
vaccination with Arepanrix and to follow-up cases to assess any atypical or differential clinical course<br />
and prognosis in any vaccinated vs. non-vaccinated subjects. This submission fulfils post authorisation<br />
measure ANX 115, therefore it is proposed to remove this condition from Annex II<br />
MAH(s): GlaxoSmithKline Biologicals S.A.<br />
16.5. Interim results of imposed and non-imposed PASS and results of<br />
non-imposed PASS submitted before the entry into force of the revised<br />
variations regulation 44<br />
16.5.1. Boceprevir – VICTRELIS (CAP)<br />
<br />
Evaluation of interim PASS results<br />
Regulatory details:<br />
PRAC Rapporteur: Isabelle Robine (FR)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002332/MEA 017.7<br />
Procedure scope: MAH’s response to MEA 017.5 (interim data on the observational PASS of Victrelis<br />
(boceprevir) among chronic hepatitis C patients (P08518) as adopted in February 2014<br />
MAH(s): Merck Sharp & Dohme Limited<br />
17. ANNEX I Renewals of the Marketing Authorisation,<br />
Conditional Renewals and Annual Reassessments<br />
Based on the review of the available pharmacovigilance data for the medicines listed below and the<br />
CHMP Rapporteur’s assessment report, the PRAC considered that either the renewal of the marketing<br />
authorisation procedure could be concluded - and supported the renewal of their marketing<br />
authorisations for an unlimited or additional period, as applicable - or no amendments to the specific<br />
obligations of the marketing authorisation under exceptional circumstances for the medicines listed<br />
below were recommended. As per agreed criteria, the procedures were finalised at the PRAC level<br />
without further plenary discussion.<br />
17.1.1. Brentuximab vedotin – ADCETRIS (CAP)<br />
<br />
PRAC consultation on a conditional renewal of the marketing authorisation<br />
Regulatory details:<br />
PRAC Rapporteur: Sabine Straus (NL)<br />
44 In line with the revised variations regulation for any submission before 4 August 2013<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/438418/2014 Page 70/75
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